Starpharma Holdings Limited

A.B.N. 20 078 532 180

4-6 Southampton Crescent

Abbotsford Victoria 3067 Australia

PO Box 2022

Preston Victoria 3072 Australia

Telephone (+613) 8532 2700

Facsimile (+613) 9510 5955

www.starpharma.com

Attention: Cheng Tang

ASX Compliance Pty Ltd Level 4, North Tower, Rialto 525 Collins Street Melbourne VIC 3000

By Email:cheng.tang@asx.com.au

7 January 2019

Dear Cheng,

Starpharma Holdings Limited (ASX:SPL) - Aware Query Request for Information

In reference to your letter dated 3 January 2019, please find answers to your request for information:

1.

Does SPL consider the information in the US FDA Announcement to be information that a reasonable person would expect to have a material effect on the price or value of its securities?

Yes.

2. If the answer to question 1 is "no", please advise the basis for that view.

Not applicable.

3.

If the answer to question 1 is "yes", when did SPL first become aware of the information?

Starpharma received a copy of the FDA notification via email from our US regulatory representative on the morning of Thursday 27 December at 9.31am (Melbourne time).

The US FDA letter, dated 26 December 2018, was electronically signed at 2.56pm US Washington time (approximately 7am on 27 December Melbourne time) and, as Starpharma is a non-US company, all official US FDA correspondence is required to be through the designated US regulatory agent. We understand that the letter was received from FDA by our US regulatory agent via email at around 4.30pm 26 December (US time), which was 8.30am 27 December in Melbourne.

The US FDA Announcement was prepared promptly and released to the market as soon as practicable after Starpharma became aware of the information.

  • 4. If the answer to question 1 is "yes" and SPL first became aware of the information before the relevant date, did SPL make any announcement prior to the relevant date which disclosed the information? If so, please provide details. If not, please explain why this information was not released to the market at an earlier time, commenting specifically on when you believe SPL was obliged to release the information under Listing Rules 3.1 and 3.1A and what steps SPL took to ensure that the information was released promptly and without delay.

    Not applicable - the information was released promptly and without delay.

  • 5. Does SPL consider the information in the Japanese PMDA Announcement to be information that a reasonable person would expect to have a material effect on the price or value of its securities?

    The Company does not consider that the information in the Japanese PMDA Announcement was likely to have a material effect on the price or value of its securities.

  • 6. If the answer to question 5 is "no", please advise the basis for that view.

    The VivaGel® condom in Japan is not a material part of Starpharma's business. The relative value of the VivaGel® condom overall has declined with the significant developments in the far more valuable DEP® platform and VivaGel® BV product over the last few years. That said, the Japanese approval remains of interest to some longstanding shareholders who have been following the progress of the VivaGel® condom and so an announcement of this development was considered appropriate. The incremental revenue from the Japanese VivaGel® condom market opportunity is not expected to be material in the context of anticipated revenues from the DEP® platform and VivaGel® BV product.

    The Company's view is supported by independent professional analyst's (Bell Potter, May 2018) modelling attributing the value of the Japanese VivaGel® condom opportunity at less than 1% of their total sum-of-parts valuation of Starpharma.

  • 7. If the answer to question 5 is "yes", when did SPL first become aware of the information?

    Although the answer to question 5 is "No", for completeness, below are the details of the timing of receipt of information by the Company.

    Starpharma received an initial email in Japanese on Friday 28 December at 4.12pm (Melbourne time) from Starpharma's Japanese partner, Okamoto. At this point, Starpharma was not aware of the nature or significance of the correspondence given that it was entirely in Japanese.

In accordance with its standard process for foreign language correspondence from foreign partners or regulators, Starpharma then sought the translation and interpretation of the correspondence from our specialist Japanese consultant. It is important to appreciate that regulatory communications in the pharmaceutical industry are typically complex and subtle differences in language can be quite material to the overall outcome. As such, the correspondence in Japanese requires specialist expertise to interpret both the foreign language and to ensure an understanding of the context and significance of the correspondence. Starpharma's experience is that reliance on standard translation tools or translators for interpretation of complex technical information is risky as the results can be quite misleading/inaccurate.

While Starpharma worked diligently to have the correspondence translated and interpreted as soon as possible, due to the weekend, proximity to the New Year and our consultant's holiday/overseas travel, there was limited availability of Starpharma's Japanese consultant and contact was particularly challenging over this period.

Given the above, Starpharma first became aware of the nature of the information in the correspondence from Okamoto on Tuesday 1 January 2019 after receiving a verbal English language translation and interpretation on the meaning of the correspondence from our specialist Japanese consultant and moved to promptly make an ASX announcement after this time.

8. If the answer to question 5 is "yes" and SPL first became aware of the information before the relevant date, did SPL make any announcement prior to the relevant date which disclosed the information? If so, please provide details. If not, please explain why this information was not released to the market at an earlier time, commenting specifically on when you believe SPL was obliged to release the information under Listing Rules 3.1 and 3.1A and what steps SPL took to ensure that the information was released promptly and without delay.

Although the answer to question 5 is "No", for completeness, below are further details of the timing of information.

Starpharma ensured that the Japanese PMDA Announcement was finalised and released to the market before open on 2 January 2019, with translation and interpretation of the content and context of the relevant correspondence being received on 1 January 2019, and that day being a non-ASX trading day.

Until the English language interpretation and translation on the meaning of the Japanese language correspondence was received by Starpharma from our Japanese consultant, the Company did not have information that would require disclosure under the ASX Listing Rules as it was not aware of the nature or significance of the subject matter of the correspondence. In fact, without the English language interpretation, any disclosure could potentially have been misleading and led to trading on an ill-informed basis as Starpharma could not confidently predict the nature of the information in the correspondence.

The Company believes that the information regarding the Japanese approval remained confidential at all times prior to disclosure of the Japanese PMDA Announcement.

9.

SPL's securities trading policy prohibits the dealing in securities while in possession of inside information (or price sensitive information). Please confirm that when the trades occurred on 28 December 2018, the Directors were in compliance with SPL's securities trading policy.

At the time the directors' trading occurred on 28 December 2018, each director was in compliance with Starpharma's securities trading policy.

We note the initial email which was both in Japanese and was received on Friday 28 December at 4.12pm (Melbourne time) was subsequent to the trading by directors on the day.

  • 10. Please confirm that SPL is complying with the Listing Rules and, in particular, Listing Rule 3.1.

    Starpharma confirms it is complying with the Listing Rules, in particular, Listing Rule 3.1.

  • 11. Please confirm that SPL's responses to the questions above have been authorised and approved in accordance with its published continuous disclosure policy or otherwise by its board or an officer of SPL with delegated authority from the board to respond to ASX on disclosure matters.

    Starpharma confirms these responses to the questions above have been authorised and approved in accordance with the Company's published continuous disclosure policy.

Yours sincerely,

Nigel Baade Company Secretary

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Starpharma Holdings Limited published this content on 07 January 2019 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 07 January 2019 06:13:04 UTC